Successful Implementation of Testing Requirements for Medical Devices that deliver breathing gas
Medical devices that deliver or convey respiratory gas to the patient, such as ventilators, anesthesia systems, CPAP devices, or breathing tubes, must be designed and tested in such a way that no health risks arise from volatile substances, particles, and/or leachable substances released into the condensate.
The ISO 18562 series of standards establishes uniform testing and evaluation procedures for the biological safety of components that convey respiratory gas.
In this training, you will learn how to systematically and efficiently implement the requirements of ISO 18562 and integrate them into your existing risk management systemin accordance withMDR and ISO 10993.
The current approach to chemical and particulate analysis and toxicological evaluationin accordance with ISO 18562 -1 through -4 will also be covered.
- Content
- Fundamentals and scope of the ISO 18562 series
- Relationship between ISO 10993 and ISO 18562
- Overview of the four parts of ISO 18562:
- Part 1: Evaluation and testing within a risk management process
- Part 2: Tests for emissions of particulate matter
- Part 3: Tests for emissions of volatile organic substances
- Part 4: Tests for leachables in condensate
- Establishment of a testing strategy based on product design and material usage
- Chemical characterization and evaluation of emissions
- Toxicological risk assessment of released substances
- Documentation and evidence management within the scope of technical documentation
- Integration into development and QM processes
- Practical examples and case studies
- Your Benefits
- You’ll understand the requirements of ISO 18562 and how it relates to the MDR and ISO 10993.
- You’ll be able to plan, evaluate, and interpret emission tests effectively.
- You will learn how to conduct toxicological assessments for respiratory gas exposures.
- You will know how to develop risk-based testing strategies and document them in a manner that meets regulatory requirements.
- You will be able to integrate the results into your quality management and risk management systems.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of ventilators and anesthesia machines
- Developers of respiratory gas delivery components
- Regulatory Affairs
- Quality Management
